IStat Troponin I AMR Validation
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I have a facility in my region that is trying to validate the lower range AMR for IStat troponin. The linearity material given by abbott only goes down to 0.42 ng/mL and the lower end of our linear range goes down to 0.00 ng/mL. Does anyone use a 3rd party kit to validate lower ranges? Is so what do you use and what lot are you currently using?
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Samples from healthy donors can be used. Refer to pg. 4 of the cTnI performance verification protocol.
We have diluted the level 1 control with negative patient plasma, usually 1:4 to get down closer to 0. We've also used negative patients too.
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